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Hydrocortisone and lidocaine

Phase 2

Hemorrhoids | Small molecule | Gastrointestinal |Citius Pharmaceuticals, Inc.|Last Updated: Feb 24, 2016

Target and mechanism

ModalitySmall molecule

Also known as Hydrocortisone acetate and lidocaine hydrochloride

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment211

FDA Designations

No designations recorded

Clinical trial landscape

Hydrocortisone and lidocaine · 1 trial · 1 indication

Phase 2 1
NCT02689856Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II HemorrhoidsHemorrhoids
COMPLETED211 Analytics
PHASE2COMPLETED
Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids
HemorrhoidsUnlock trial analytics

Study Endpoints

Primary Endpoints

Global score of disease severity
up to 14 days

A measure overall discomfort on a scale of 0 to 5

Secondary Endpoints

Individual signs and symptoms
up to 14 days
Onset of relief of symptoms
4 hours following product administration
Recurrence of symptoms
4 hours following product administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Vehicle creamPLACEBO_COMPARATORPlacebo control base cream
3% hydrocortisoneEXPERIMENTAL3% Hydrocortisone acetate cream
0.5% hydrocortisoneEXPERIMENTAL0.5% Hydrocortisone acetate cream
5% lidocaineEXPERIMENTAL5% Lidocaine hydrochloride cream
1% lidocaineEXPERIMENTAL1% Lidocaine hydrochloride cream
3% Hydro 5% LidoEXPERIMENTALHydrocortisone acetate and lidocaine hydrochloride at 3% and 5% cream
0.5% Hydro 1% LidoEXPERIMENTALHydrocortisone acetate and lidocaine hydrochloride at 0.5% and 1% cream

Interventions

NameTypeDescription
Hydrocortisone acetate and lidocaine hydrochlorideDRUGHydrocortisone and lidocaine in combination
Placebo controlDRUGVehicle cream alone
Hydrocortisone acetateDRUGhydrocortisone alone
Lidocaine hydrochlorideDRUGlidocaine alone
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Subject is male or non-pregnant female 18 years of age or older, in generally good health. Females must be post-menopausal, surgically sterile or have a negative urine pregnancy test (UPT) at the Baseline Visit and agree to use birth control during the study. 2. Subject has p...

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